# K023842: Clearfil SE Bond Plus

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Feb 11, 2003 after 85 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K931812 (1993). 37 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012442: Modification to Clearfil SE Bond, Kuraray Medical, Inc. (2001)
- K012440: Modification to Clearfil Liner Bond 2V, Kuraray Medical, Inc. (2001)
- K993917: Tokuyama One-UP-Bond F, Tokuyama America, Inc. (2000) Summary page 1.
- K953612: Imperva Fluorobond, Shofu Dental Corp. (1995) Summary page 1.
- K982394: Prime & Bond NT Dual Cure Universal Dental Adhesive System, Dentsply Intl. (1998) Summary page 1.
- K014027: Optibond Solo Plus 4, Kerr Dental Materials Center (2002)
- K012441: Panavia F, Kuraray Medical, Inc. (2001)
- K021805: Seal & Protect Protective Sealant, Dentsply Intl. (2002) Summary page 1.
- K855211: Panavia EX, a Dental Adhesive, Kuraray Co. (1986) Summary page 1.
- K012707: Estenia, Kuraray Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- K183391: Novidia Universal Bond (2019), 0 descendants of its own
- K122522: Dentoetch Quickbond Bond Activator (2013), 0 descendants of its own
- K070956: SEA2 Self Etch Adhesive (2007), 0 descendants of its own

## Indications for use
CLEARFIL SE BOND PLUS is indicated for the following applications: 1) Direct restorations using light-cured composite resin or compomer 2) Cavity sealing as a pretreatment for indirect restorations 3) Treatment of hypersensitive and/or exposed root surfaces 4) Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics or composite resin using light-cured composite resin 5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin 6) Core build-ups using light- or dual-cured composite resin 7) Cavity sealing under amalgam restorations

Source page: https://510kreport.com/device/K023842
Methodology: https://510kreport.com/methodology